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Negative Pressure Suction for Oropharyngeal Dysphagia

N/A

Recruiting

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Exhaustion of conventional treatment options (physical, medical, and surgical therapies)

Gastrostomy tube dependence

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measurement of the pharyngeal area during maximum contraction are taken after administration of 20 cc liquid barium. the pharyngeal area at rest is measured when 1 cc bolus is held in the oral cavity.

Awards & highlights

Study Summary

This trial will test whether using a suction device during a swallowing exam can help prevent aspiration among patients with difficulty swallowing.

Who is the study for?

This trial is for patients with oropharyngeal dysphagia who have a high risk of food entering their airway, rely on tube feeding, and haven't improved with standard treatments. It's not for those with severe throat narrowing, cognitive issues preventing cooperation, active cancer, no feeding tube, or recent cancer survivors.Check my eligibility

What is being tested?

The study tests if using a negative pressure suction catheter in the throat can reduce aspiration (food going into the lungs) during swallowing exams in people with difficulty swallowing.See study design

What are the potential side effects?

Potential side effects may include discomfort from the catheter placement and possible irritation to the throat area due to suction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You have tried all standard treatment options, including physical therapy, medication, and surgery.

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You rely on a feeding tube that goes through your stomach.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from when bolus head first passes posterior nasal spine to time bolus head enters base of vallecula

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from when bolus head first passes posterior nasal spine to time bolus head enters base of vallecula

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from when bolus head first passes posterior nasal spine to time bolus head enters base of vallecula for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Degree of aspiration

Pharyngo-esophageal Segment (PES) opening size

Secondary outcome measures

Hypopharyngeal transit time

Oropharyngeal transit time

Pharyngeal Constriction Ratio (PCR)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Negative Pressure Suction DeviceExperimental Treatment1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor

910 Previous Clinical Trials

4,706,981 Total Patients Enrolled

Media Library

Negative Pressure Suction Catheter (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03368079 — N/A

Oropharyngeal Dysphagia Research Study Groups: Negative Pressure Suction Device

Oropharyngeal Dysphagia Clinical Trial 2023: Negative Pressure Suction Catheter Highlights & Side Effects. Trial Name: NCT03368079 — N/A

Negative Pressure Suction Catheter (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03368079 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is the maximum capacity of this clinical trial?

"Affirmative. According to clinicaltrials.gov, the trial posted on January 30th 2016 is still recruiting patients with 10 individuals required from a single research centre."

Answered by AI

Are there still open spots available for this experiment?

"Affirmative. Clinicaltrials.gov data reveals that this research project, which was first posted on 30th January 2016, is currently seeking enrolment. Ten participants must be sourced from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Utilization of Negative Pressure Suction to Reduce Aspiration in Oropharyngeal Dysphagia

2016. "Utilization of Negative Pressure Suction to Reduce Aspiration in Oropharyngeal Dysphagia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03368079.

All > Dysphagia